Wellue ER1 Heart HealthMonitor User Manual

Wellue ER1 Heart HealthMonitor User Manual

NOTICE
It’s not intended for medical use or treatment. It’s marketed as a consumer wellness product.

Introduction

Thank you for choosing the ER1 heart health monitor (hereinafter ER1 monitor). ER1 monitor is to acquire, record, and store adult ambulatory ECG data. The ECG data from the ER1 monitor can be automatically analyzed when uploaded to the accompanying PC software.

Composition
The ER1 monitor box contains:

• ER1 main unit
• A power/data cable for charging and exporting
• A USB drive with the analysis software (ECGbrowser)
• A pack of disposable electrodes (10 pieces)
• Chest strap

Monitor Views

1. The “R” symbol Indicates this side should be placed rightwards.
2. LED indicator
   

   With light	Light flashing	l Yellow light: Low battery l Flash every 5 seconds: Standby l Flash when applied: Synchronous with the heartbeat.
   	On	l Green light: Fully charged l Yellow light: Charging
   No light	/	Battery depleted.

3. Electrode button It is to be used with a chest strap, disposable electrode, or power/data cable.
4. Power contact It is used to connect the power/data cable.

Getting Started

First Use
After removing the packing, charge the device at first foractivation

Charge Battery
This device uses a rechargeable lithium battery. Chargeit through the following steps:

1. Connect the main unit with the power/data cable, as shown
   
2. Connect the other end of the cable to the power source/USB connector, like a laptop or power adapter

Wear ER1 Monitor
Before wearing the ER1 monitor, you need to decide to use which way to apply it to your body. The device is designed application through the

• With electrodes
• With chest strap

You can choose one way to apply it to acquire data.

With Electrodes

1. Take two accompanying disposable electrodes and remove their packing.
2. Connect the electrodes with the ER1 main unit, as shown
   
3. Apply the device to the left chest, as shown below. The“R” symbol is rightward and near the middle of the sternal notch, and the other end is leftward and 45° lower than the horizontal level.

With Chest Strap

1. Take the accompanying chest strap and remove its packing.
2. Install the ER1 main unit to the strap, as shownbelow
   
3. Moisten the electrode on the strap to contact the body water
   
4. Adjust the chest strap length to suit your body.
5. Put on the strap with the “R” symbol on the right side, and position the strap under the breast, as shown below

Start and Stop Recording

Start Recording
Once you wear the ER1 monitor, the device starts acquiring ECG data.

Stop Recording
When 60 seconds elapse after you remove the ER1 monitor, the monitor stops acquiring ECG data and saves it.

Attention
The device can store 10 recordings, 30 hours in total. When the recordings exceed 10 pieces or the total time reaches 30 hours, the earliest data will be covered with a new one. One single recording can only store 24 hours of data at most. For the safety of your data, export it to the ECGBrowsereach time after you have measured ECG.

Install ECG Browser

When you want to analyze the acquired ECG data in yourER1monitor, you need to install the ECG browser on your PC or laptop. Then you can import the data into the ECGbrowser and make an analysis online.

Follow the steps below to install the ECG browser:

1. Plug the USB drive accompanied to the USBconnectoronyourPC or laptop.
2. Copy the file of ECG Browser Setup vxx. exe to your local drive.
3. Run the file.
4. Select the appropriate language.
5. Select the defaults until finish installation.

Registration and Login
When you first use this browser, you need to register.

1. Run the on the desktop on your PC or laptop.
2. In the lower part of the pop-up screen, select “Register now”.
3. Enter your email address, verification code, and password.
4. Select “Agree to and accept Terms of Use and Privacy Policy”.
5. Select the “Register now” button.

After you have registered, you just run

to log in each time you use this browser.

Make an Analysis

1. Make sure that your PC or laptop is connected to the Internet.
2. Connect the ER1 monitor to your PC or laptop with the power/data cable.
3. Log in to the ECG Browser.
4. Select the “Download Data” button.
5. Create or select a user. Then the data will automatically be imported into the browser and
   
6. Select “Go to analysis”.
7. Wait till the analysis result is returned.
8. Select “View Report”

Additional Operations

• Save the waveform data in PDF by selecting“SaveasPDF” in the “View Waveform” window.
• Delete the recordings by selecting the “Delete” button.
• Analyze the data in batch by selecting the “BatchAnalysis”button.
• Set the storage directory in the “Setting” window.
• Change the password by selecting the icon.

Attention
The report and waveform data are saved in the default directory. If you change the storage directory, the previously stored recordings will not be seen in the task list. The default directory is C:/User/AppData/Local/ECGBrowser/Data.

Warnings

General
Before using this device, read this manual carefully and understand the warnings and risks. Do not use acetone or other volatile solutions to clean the device. Do not strongly collide or crush the device. If the casing is broken, stop using it. Do not disassemble the device at will, otherwise it may cause machine malfunction or affect the normal operation of the device. Keep the device out of the reach of children and pets. The device should not be maintained while in use.

Analysis
The device is not intended to replace the medical diagnosis of a professional physician. The results of this device are for reference only and cannot be directly used as a basis for clinical treatment. The device cannot be used to diagnose a disease directly. Please consult your doctor. The measurement results of this device cannot distinguish all diseases. If your body feels unwell, you should consult your doctor immediately, in addition to the measurement results of this device.

Do not self-diagnose and take medication based on the measurements of this device without consulting your doctor. In particular, do not take new medications without prior permission. The device is not a substitute for professional heart or other organ function measurement equipment. Medical ECG measurement requires more professional and complete measurements. We recommend that you record your ECG waveform and the analysis results, and provide them to your doctor if necessary.

Battery

The built-in rechargeable lithium battery cannot be replaced. Non-professionals shall not open the casing, and modify or replace the battery. Do not expose the main unit to high temperatures such as ovens, water heaters, and microwave ovens. Overheating may cause battery explosion. If the battery leaks, keep your skin and eyes free from leaking liquids. If skin or eyes come into contact with leaking liquid, rinse your skin or eyes immediately and go to the hospital for treatment. Lithium battery capacity will decrease after charge-dischargefor300 times.

• Cleaning
  ER1 monitor and strap need to be cleaned regularly. Cleanthed device per week. Carefully wipe the device with a clean, soft cloth or cotton ball with 75% medical alcohol or water.

Recycling
Do not casually dispose of the main unit and its accessories at the end of their service life. They shall be disposed of following local regulations. When they are intended to be discarded,they must be sent to the appropriate facility for recycling

Troubleshooting

Cannot acquire data normally.
Solution: Charge the device. If the problem continues, contact the distributor

ECG waveform is of much interference. Solution:

• Adjust the position of the ER1 monitor.
• Replace the ECG disposable electrodes, or moisten the chest strap with water.

Recordings cannot be imported into the ECGBrowser. Solution:

• Charge the device.
• Try another operating system.

Appendix
Specifications

Classification
EC Directive	MDD, 93/42/EEC
	RED, 2014/53EU
	ROHS 2.0, 2011/65/EU
Degree protection against electrical shock	Type CF
Environment
	Operating	Storage
Temperature	5 – 45°C	-25 – 60°C
Relative humidity (non-condensing)	10% – 95%	10% – 95%
Atmospheric pressure	700-1060 hPa	700-1060 hPa
Degree of dust & water resistance	IP22
Drop test	1.0 m
Power supply
Type of battery	Rechargeable lithium polymer battery
Battery specification	3.7Vdc, 90mAh
Battery run time	72 hours (fully charged)
Charging input voltage range	4.5 – 5.5v DC voltage

Charging time	2 hours (to 90% power)
ECG
Lead type	Single-lead ECG
Lead	Lead II
Input impendence	≥10MΩ, 10Hz
Linearity and dynamic range	10mV (peak-to-valley)
Common mode rejection	≥60dB
Frequency response	0.67 – 40 Hz
Gain error	Maximum error ±10%
Physical
Size	100×23×8.3 mm
weight	<35 g (with battery)
Expected service life	5 year

 ECG Browser Installation Specifications Hardware CPU: P4 1.7GHz or above Memory: 1GB or above Storage: Free disk space greater than 200MBOperating System
Support Windows 7 and 10

Symbols

Symbol	Description
	Type BF-Applied Part
	Manufacturer
	Date of manufacture
	Authorized Representative in the European Community
	Follow Instructions for Use.
	MRI is unsafe. Presents hazards in all MR environments as the device contains strongly ferromagnetic materials.
	Protected against spraying water and against access to hazardous parts with a tool, per IEC60529.
	Serial number
	No alarm system
	Temperature limitation

 

	Humidity limitation
	Atmospheric pressure limitation
	Indicate separate coll

FCC Warning:

Any Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

Note:
This equipment has been tested and found to comply with the limits for a Class B digital device, under part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used by the instructions, may cause harmful interference to radio communications.

However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and the receiver.
• Connect the equipment to an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help

The device has been evaluated to meet general RF exposure requirements. The device can be used in portable exposure conditions without restriction.

REFERENCE LINK